Laparoscopic Total Left-Sided Surgical Approach Versus Traditional Bilateral Surgical Approach For Treating Hiatal Hernia: A Study Protocol For A Randomized Controlled Trial

Background: In China, guidelines for the treatment of hiatal hernia (HH) are lacking. Furthermore, efficacy and safety assessments of surgical approaches for HH and for the protection of the vagus nerve and organ function are needed. Therefore, the present clinical trial is being conducted to establish the normative treatment for HH.Methods: The current trial is an ongoing, single-center, randomized controlled trial of patients with HH. The total sample size required for the trial (July 2020-December 2023) is approximately 114 patients. Patients will be randomly assigned to either an experimental group (total left-sided surgical approach; TLSA) or a control group (traditional bilateral surgical approach; TBSA) at a ratio of 1:1 using the block randomization method. We will use case report forms (CRFs) and electronic data capture (EDC) systems to obtain demographic information, preoperative laboratory tests, auxiliary examination results, operation information, and postoperative condition. The patients will be followed up for 3 years after surgery. The primary endpoint is the gastrointestinal quality-of-life index (GIQLI) at 1 year. The secondary endpoints include an efficacy evaluation index [consisting of the incidence of gallstones and gastric emptying disorders, gastrointestinal function recovery time, visual analog scale (VAS) scores, objective evaluation of postoperative indices, and surgical information] and a safety evaluation index (consisting of the incidence of postoperative complications, the 30-day postoperative mortality rate, and the HH recurrence rate at 1 and 3 years after surgery). Discussion: TLSA can protect the normal physiological function of organs to a certain extent by protecting the vagus nerve from injury, and has satisfactory short-and long-term efficacy. There is no significant difference in the incidence of postoperative complications and surgical safety between TLSA and TBSA. Our findings will facilitate clinical decision-making for HH and improve the life quality of patients.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000034028 (registration date: June 21, 2020).Background: In China, guidelines for the treatment of hiatal hernia (HH) are lacking. Furthermore, efficacy and safety assessments of surgical approaches for HH and for the protection of the vagus nerve and organ function are needed. Therefore, the present clinical trial is being conducted to establish the normative treatment for HH. Methods: The current trial is an ongoing, single-center, randomized controlled trial of patients with HH. The total sample size required for the trial (July 2020-December 2023) is approximately 114 patients. Patients will be randomly assigned to either an experimental group (total left-sided surgical approach; TLSA) or a control group (traditional bilateral surgical approach; TBSA) at a ratio of 1:1 using the block randomization method. We will use case report forms (CRFs) and electronic data capture (EDC) systems to obtain demographic information, preoperative laboratory tests, auxiliary examination results, operation information, and postoperative condition. The patients will be followed up for 3 years after surgery. The primary endpoint is the gastrointestinal quality-of-life index (GIQLI) at 1 year. The secondary endpoints include an efficacy evaluation index [consisting of the incidence of gallstones and gastric emptying disorders, gastrointestinal function recovery time, visual analog scale (VAS) scores, objective evaluation of postoperative indices, and surgical information] and a safety evaluation index (consisting of the incidence of postoperative complications, the 30-day postoperative mortality rate, and the HH recurrence rate at 1 and 3 years after surgery). Discussion: TLSA can protect the normal physiological function of organs to a certain extent by protecting the vagus nerve from injury, and has satisfactory short- and long-term efficacy. There is no